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Lenalidomide and Rituximab as Treatment of Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00759603
First received: September 24, 2008
Last updated: July 27, 2015
Last verified: July 2015
Results First Received: July 27, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Interventions: Drug: Lenalidomide
Drug: Rituximab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: September 22, 2008 to November 02, 2009. All recruitment done at The University of Texas MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One of the 60 participants enrolled was excluded from the trial before any treatment assignment.

Reporting Groups
  Description
Lenalidomide + Rituximab Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.

Participant Flow:   Overall Study
    Lenalidomide + Rituximab
STARTED   59 
COMPLETED   59 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lenalidomide + Rituximab Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.

Baseline Measures
   Lenalidomide + Rituximab 
Overall Participants Analyzed 
[Units: Participants]
 59 
Age 
[Units: Years]
Median (Full Range)
 62 
 (42 to 82) 
Gender 
[Units: Participants]
 
Female   13 
Male   46 
Region of Enrollment 
[Units: Participants]
 
United States   59 


  Outcome Measures

1.  Primary:   Overall Participant Response Rate: Percentage of Participants With Complete + Partial Response According to Revised National Cancer Institute-sponsored Working Group Guidelines   [ Time Frame: Responses assessed after 12 cycles, up to 48 weeks with interim assessments performed after 3, 6 and 12 cycles. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alessandra Ferrajoli, MD/Professor, Leukemia
Organization: The University of Texas (UT) MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00759603     History of Changes
Other Study ID Numbers: 2007-0208
NCI-2012-01674 ( Registry Identifier: NCI CTRP )
Study First Received: September 24, 2008
Results First Received: July 27, 2015
Last Updated: July 27, 2015
Health Authority: United States: Food and Drug Administration